FDA.reportPublic FDA data

Vaku-8

Primary DI
08903347023478
Brand
Vaku-8
Company
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
Model
"25 G X ¾"""
Catalog number
02347
Device description
"VAKU-8 Blood Collection Set, 25G X ¾"" (0.50X19MM) 12"" TUBE MYCO REORDER # SVMS-25A"
Published
2017-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000592000UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SETMyco Medical Supplies, Inc.2001-04-12FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18903347023475PackageGS1100In Commercial Distribution
28903347023472PackageGS110In Commercial Distribution
58903347023473PackageGS118In Commercial Distribution
08903347023478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1890334702347518903347023475
2890334702347228903347023472
5890334702347358903347023473
08903347023478089033470234788903347023478

GMDN Terms#

Term, Definition table
TermDefinition
Venous butterfly needle/setAn invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device.

Regulatory Flags#

DUNS number
862318107
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08903347051891UNOLOK3ml (22G x 1 1/2'')051892024-06-25
18903347051898UNOLOK3ml (22G x 1 1/2'')051892024-06-25
08903347023461Vaku-8"23 G X ¾"""023462017-01-09
08903347002336UNOLOK+"19 G X ¾"""002332017-04-26
08903347002343UNOLOK+ "21 G X ¾"""002342017-04-26
08903347002350UNOLOK+ "23G X ¾"""002352017-04-26
08903347002367UNOLOK+ "25G X ¾"""002362017-04-26
08903347003241UNOLOK"19 G X ¾"""003242017-04-26
08903347003265UNOLOK "21 G X ¾"""003262017-04-26
08903347003272UNOLOK"22G X ¾"""003272017-04-26
08903347003289Unolok"23 G X ¾"""003282017-01-09
08903347003302Unolok"25 G X ¾"""003302017-01-09
08903347023423VAKU-8+ "21 G X ¾"""023422017-04-26
08903347023430VAKU-8+ "23G X ¾"""023432017-04-26
08903347023447VAKU-8+ "25G X ¾"""023442017-04-26
08903347023454Vaku-8"21 G X ¾"""023452017-01-09
08903347034696VAKU-8 "22G X 3/4"""034692017-04-26
18903347023468Vaku-823 G X ¾"023462017-01-09
18903347023475Vaku-825 G X ¾"023472017-01-09

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Primary DI, Brand, Company table
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05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
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05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
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05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
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04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06